ALASKA STATE LEGISLATURE
SENATE HEALTH AND SOCIAL SERVICES STANDING COMMITTEE
February 10, 2017
1:30 p.m.
MEMBERS PRESENT
Senator David Wilson, Chair
Senator Natasha von Imhof, Vice Chair
Senator Cathy Giessel
Senator Peter Micciche
Senator Tom Begich
MEMBERS ABSENT
All members present
COMMITTEE CALENDAR
SENATE BILL NO. 20
"An Act classifying U-47700 as a schedule IA controlled
substance; and providing for an effective date."
- MOVED CSSB 20(HSS) OUT OF COMMITTEE
SENATE BILL NO. 32
"An Act relating to biological products; relating to the
practice of pharmacy; relating to the Board of Pharmacy; and
providing for an effective date."
- HEARD & HELD
PREVIOUS COMMITTEE ACTION
BILL: SB 20
SHORT TITLE: LIST U-47700 AS A CONTROLLED SUBSTANCE
SPONSOR(s): SENATOR(s) MEYER
01/18/17 (S) READ THE FIRST TIME - REFERRALS
01/18/17 (S) HSS, JUD
02/08/17 (S) HSS AT 1:30 PM BUTROVICH 205
02/08/17 (S) Heard & Held
02/08/17 (S) MINUTE(HSS)
02/10/17 (S) HSS AT 1:30 PM BUTROVICH 205
BILL: SB 32
SHORT TITLE: PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS
SPONSOR(s): SENATOR(s) HUGHES
01/23/17 (S) READ THE FIRST TIME - REFERRALS
01/23/17 (S) HSS, L&C
02/10/17 (S) HSS AT 1:30 PM BUTROVICH 205
WITNESS REGISTER
CHRISTINE MARASIGAN, Staff
Senator Kevin Meyer
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: Explained the CS for SB 20 on behalf of the
sponsor.
SENATOR KEVIN MEYER
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: Sponsor of SB 20.
SENATOR SHELLEY HUGHES
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: Sponsor of SB 32.
AIMEE BUSHNELL, Staff
SENATOR SHELLEY HUGHES
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: Provided an overview and sectional analysis
of SB 32 on behalf of the sponsor.
RYLAN HANKS, Director
Global R&D and Regulatory Policy
Amgen Incorporated
Los Angeles, California
POSITION STATEMENT: Testified in support of SB 32.
DR. DAVID CHARLES, Chair
Alliance for Patient Access
Nashville, Tennessee
POSITION STATEMENT: Testified in support of SB 32.
DR. PHILIP SCHNEIDER, Chair
Advisory Board
Alliance for Safe Biologic Medicines
Phoenix, Arizona
POSITION STATEMENT: Testified in support of SB 32.
MARK GUIMOND
Director of State Legislative Affairs
Arthritis Foundation
Washington, D.C.
POSITION STATEMENT: Testified in support of SB 32.
GARY MCCLELLAND
Patient Advocate
Anchorage, Alaska
POSITION STATEMENT: Testified in support of SB 32.
ROBERT THOMS, representing himself
Wasilla, Alaska
POSITION STATEMENT: Testified in support of SB 32.
CINDY CASERTA, representing herself
Wasilla, Alaska
POSITION STATEMENT: Testified in support of SB 32.
ASHLYN ANTONELLI, representing herself
Anchorage, Alaska
POSITION STATEMENT: Testified in support of SB 32.
EMILY NENON, Alaska Government Relations Director
American Cancer Society Cancer Action Network
Anchorage, Alaska
POSITION STATEMENT: Testified in support of SB 32.
DR. BARRY CHRISTENSEN, Co-Chair
Alaska Pharmacist Association
Ketchikan, Alaska
POSITION STATEMENT: Testified that the Alaska Pharmacist
Association is neutral on SB 32.
LIS HOUCHEN, Chair
National Association of Chain Drugstores
Anchorage, Alaska
POSITION STATEMENT: Testified that the National Association of
Chain Drugstores is neutral on SB 32 if notification were
changed from three-business days to five-business days.
ACTION NARRATIVE
1:30:19 PM
CHAIR DAVID WILSON called the Senate Health and Social Services
Standing Committee meeting to order at 1:30 p.m. Present at the
call to order were Senators Giessel, Begich, von Imhof, and
Chair Wilson.
SB 20-LIST U-47700 AS A CONTROLLED SUBSTANCE
1:30:48 PM
CHAIR WILSON announced the consideration of SB 20. He noted the
proposed committee substitute (CS), 30-LS0319\D.
1:31:19 PM
SENATOR VON IMHOF moved to adopt the work draft CS for SB 20,
version 30-LS0319\D, as the working document.
CHAIR WILSON asked if there was an objection to adopting the CS.
SENATOR VON IMHOF objected for discussion purposes.
1:32:07 PM
SENATOR MICCICHE joined the committee meeting.
1:32:16 PM
CHRISTINE MARASIGAN, Staff, Senator Kevin Meyer, Alaska State
Legislature, Juneau, Alaska, explained the CS for SB 20 as
follows:
Page 4, line 30:
Misspelling corrected, adding a "z" in the word that
was brought up by Dr. Butler.
Page 4, line 31:
There's a new Section 2, this new section continues on
page 5, lines 1-6 which basically inserts the language
to have tramadol be Schedule IVA controlled substance
thus bringing Alaska statute in line with what has
already happened on the national level of tramadol.
CHAIR WILSON asked if the objection to the CS is maintained.
1:33:05 PM
SENATOR VON IMHOF removed her objection.
CHAIR WILSON announced that without objection, the CS for SB 20,
version D, is adopted by the committee.
SENATOR MICCICHE asked to comment prior to moving the bill out
of committee. He stated that the things that he has been looking
at to try and present more of a catch-all moving forward needs
more work. He asserted that the bill definitely improves the
situation and he is very supportive. He said he will be getting
with those that are experts, including [Senator Giessel], to
work on recommendations going forward.
CHAIR WILSON stated that he appreciated Senator Micciche's
comment and noted that all committee members would like a more
in-depth solution to the matter that plagues the state's
communities.
SENATOR KEVIN MEYER, Alaska State Legislature, Juneau, Alaska,
Sponsor of SB 20. Commented as follows:
I certainly agree with Senator Micciche and I think we
had a really good discussion on this topic and how we
need to come up with a system so that we can react
quicker, faster, be a little more nimble than waiting
for us to come into session and go through the process
of passing a law; although, we are creating a new law
with a pretty severe crime. So, I think it does
deserve a deliberative process, but I would agree I
think Senator Giessel and her opioid task force might
be a good place to start the discussion or this
committee and we are certainly very supportive and
want to help in any way we can, but at least what this
will do now is get this particular bill or this
particular drug which we know is currently a serious
problem, unlawful and against the law, so that the
police force can now start implementing appropriate
penalties.
CHAIR WILSON disclosed that the plan in future weeks is to have
the Statewide Drug Enforcement Unit and the Alaska Opioid Policy
Task Force present options before the committee to solve the
problem that SB 20 addresses.
SENATOR MEYER thanked Chair Wilson.
CHAIR WILSON asked if there is any objection to Senator von
Imhof's motion to move SB 20.
1:35:29 PM
SENATOR VON IMHOF moved to report the CS for SB 20, version D,
from committee with individual recommendations and attached
fiscal note(s).
1:35:39 PM
CHAIR WILSON announced that seeing no objection, CSSB 20(HSS)
moved from the Senate Health and Social Services Standing
Committee.
1:35:48 PM
At ease.
SB 32-PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS
1:37:36 PM
CHAIR WILSON announced the consideration of SB 32.
1:38:05 PM
SENATOR SHELLEY HUGHES, Alaska State Legislature, Juneau,
Alaska, sponsor of SB 32, set forth that the bill will provide
Alaskans with safe access to new U.S. Food and Drug
Administration (FDA) approved treatment options called,
"interchangeable biological products." She detailed as follows:
Under current state law pharmacists can prescribe
lower-cost generic drugs for the prescribed drug, but
currently there's absolutely no provision pertaining
to biologic medicines.
The urgency of this bill is twofold:
1. Right now a pharmacist could technically
substitute a biosimilar for a biologic product
and not be in violation of state law because we
don't have anything preventing that.
2. Within a year the FDA will begin to be approving
interchangeable biologic products.
We've had biologic products around for years, Humira
is one that is used for arthritis as an example; but,
now being developed are the biosimilars and there also
are a number of those on the market which a doctor can
now prescribe and a pharmacist can dispense in Alaska.
What we are talking about is a new category of
interchangeable biosimilars.
A generic drug is chemically based and so it can be
reproduced identically, the chemistry, the cellular
structure. A biological product is different, it is
made from a living organism and so biosimilar does not
have an absolutely identical structure to the original
biological products. So, a biosimilar is going to be
as the word indicates, "similar, but not absolutely
identical;" however, the new category that FDA is
working on, the interchangeable, the goal will be that
it will be extremely similar so that if a substitute
were dispensed, it would be expected that there would
not be the adverse reactions of something that is
quite different.
SENATOR HUGHES set forth that SB 32 would be very good for
Alaska in reference to the state's Medicaid budget. She revealed
that all of the states that have passed legislation similar to
SB 32 have indicated savings expectations for Medicaid as well
as family budgets. She noted that Missouri has "gone out on the
limb" regarding interchangeable biological products and
projected an overall savings between federal and state Medicaid
budgets of over $100 million. She conceded that Alaska will not
see similar savings due to the state's smaller population, but
asserted that every dollar counts at this point in Alaska.
1:42:23 PM
AIMEE BUSHNELL, Staff, Senator Shelley Hughes, Alaska State
Legislature, Juneau, Alaska, provided an introductory statement
on SB 32 as follows:
SB 32 follows model-consensus language that has been
worked on extensively and agreed by numerous patient-
advocacy groups, along with prescriber-association
groups and pharmacists throughout the country; most of
these specialty organizations and patient
organizations use biologics primarily in treating
specialty and serious conditions like cancer,
rheumatoid arthritis, multiple sclerosis (MS), and
other neurological disorders. There also has been
significant outreach and discussion with Alaska
stakeholders for months, some of which may be
testifying today.
She explained that to allow access to interchangeable biologics
with the necessary agreed upon safety provisions, SB 32 provides
the following:
1. Defines the relevant terms of "biological product,"
"interchangeable biological product," consistent with
federal law.
2. Limits substitution of biologics to only those biosimilars
approved as interchangeable by the FDA.
3. Preserves the ability for prescriber to prevent
substitution and allows prescribers to write, "Dispense as
written" to keep the patient taking what they believe is in
their best interest.
4. Requires the pharmacists to maintain communication with the
prescriber of the specific drug dispensed by electronic
means if accessible and if not, by phone, fax or prevailing
means and to maintain a record; so it won't be to just the
pharmacist's discretion, there is also communication
involved between the prescriber, the pharmacist and the
patient.
1:44:25 PM
MS. BUSHNELL proceeded with a sectional analysis of SB 32 as
follows:
Sec. 1 - AS 08.80.030:
Adds a new subsection requiring the Board of Pharmacy
to have a link on the board's website to the FDA's
list of approved interchangeable biological products.
Sec. 2 - AS 08.80.294:
Amends this section by requiring a pharmacist to
include on the label of a biological product container
the proprietary or proper name of the biological
product; this section also includes language to
differentiate between drugs that are and are not
biological products to ensure that statutes regarding
equivalent generic drugs are not substantively
changed.
Sec. 3 - AS 08.80.294:
Adds a new subsection to define the term "proper name"
being the name that reflects scientific
characteristics of a biological product; this new
subsection also defines "proprietary name" which is
the trademarked and registered name of the product.
Sec. 4 - AS 08.80.295:
Adds language to differentiate between equivalent drug
products and interchangeable biological products, it
prevents substitution if the prescriber indicates
"Dispense only as written;" this is similar to what
has already been in law for generic chemical drugs.
Also provides that a pharmacist who substitutes a
biologic in compliance with this section in law incurs
no greater liability than what is incurred in filling
the original prescription, also similar to what is
already in law for generic chemical drugs.
Sec. 5 - AS 08.80.295:
Adds new subsections to provide guidelines as to how
pharmacists or their designee will need to communicate
with a prescribing doctor when dispensing a biological
or interchangeable biological product if an
interchangeable product is available.
Under subsection (c), a pharmacist must communicate to
the prescribing doctor the name and manufacturer of
the biological product provided to the patient; this
communication must happen within three days after
dispensing the product by an entry through an
interoperable electronic medical records system, an
electronic prescribing technology, a pharmacy benefit
management system, or a pharmacy record. If an entry
under this subsection is not possible, the pharmacist
may communicate by e-mail, telephone, fax, or by any
other prevailing means.
Under subsection (d) provides an exception to the
communication requirement under (c) if the dispensed
biological product is a refill of the prescription and
is the same biological product. Subsection (e)
provides that communication provided under (c)(1) of
this section is providing notice to the prescribing
doctor. Under subsection (f), a pharmacist is required
to maintain a record for two years after a biological
product is dispensed. Finally subsection (g) defines
"designee" as an agent or employee of a pharmacist who
has been authorized to communicate information under
subsection (c).
Sec. 6 - AS 08.80.480(34):
Changes language and gives option to change the term
"drug" and "equivalent drug" to "biological product"
and "interchangeable biological product".
Sec. 7 AS 08.80.480:
Adds new subsection (37) to define term "biological
product".
Adds new subsection (36) to define term
"interchangeable biological product" as a biological
product as determined by the United States Food and
Drug Administration.
Under subsection (A) provides that it meets the
standard for interchangeability under U.S. code
(Regulation of biological products, Safety standards
for determining interchangeability).
Under subsection (B) provides that it is
therapeutically equivalent in the most recent edition
of the United States Food and Drug Administration
evaluations.
Sec. 8 AS 08.80.480:
Amends this section by adding transition regulations
if necessary to implement changes made by this Act.
Having changes take place in accordance with AS 44.62
(Administrative Procedure Act) but not before the
effective date of this Act.
Sec. 9 AS 08.80.480:
Adds language that section 8 of this Act takes effect
July 1, 2017.
Sec. 10 AS 08.80.480:
Adds language that this Act will take effect January
1, 2018, except for a provided in section 9.
1:46:08 PM
SENATOR VON IMHOF asked if physicians will be able to check a
box on their prescription pads that says, "No biosimilar
substitutions." She stated that she believed physicians
currently have a check-box that says, "No generic
substitutions."
SENATOR HUGHES explained that prescription pads are different.
She suggested that [Senator Giessel] could possibly provide
input on prescription pads. She said her understanding is that
some prescribers can check-off or write, "Dispense as written."
She added that a prescriber considering an interchangeable
biologic may also write, "Call if the substitute is available"
and that way the prescriber will know exactly what the patient
would or would not be taking.
SENATOR VON IMHOF noted that something similar has passed in 26
states already. She said sometimes there are questions from
doctors on being notified within a certain time frame. She asked
how many days the notification period is.
SENATOR HUGHES disclosed that the topic Senator von Imhof
addressed involved a lot of groups and has been thoroughly
debated and vetted. She revealed that the notification topic was
initially a tug-of-war because pharmacists preferred to be able
to just substitute like they do with the generics and they don't
want to have to make a request or to even notify; on the other
hand, the prescribers often wanted to make sure that a request
came in first. She added that the patient wants their medicine
as soon as possible, but a timely response from a prescriber is
very unlikely. She reiterated that bearing in mind the patient's
needs, prescribers can indicate, "Dispense as written" and also
add, "Call if a substitute is available." She said the
prescription-pad notations seemed to be the consensus language
across the nation that seems to work and addresses the needs of
busy pharmacists, patients who need their medicine right away,
and prescribers who want to make sure they know what their
patients are taking.
1:49:19 PM
CHAIR WILSON inquired if Senator Hughes knew what percentage of
doctors actually write, "As prescribed" for their prescriptions.
He noted that he is concerned about adverse effects for
substituting medications for biologicals. He added that many
doctors may not know about the side effects of substituting
medications for biological drugs.
SENATOR HUGHES replied that once the FDA begins to put medicines
in the new category of "interchangeable," the medicines will be
extremely similar. She noted that as testing continues, the
intent is to make sure biologicals are similar to a generic with
no problems. She asserted that the drug manufacturers do not
want problems and will be monitoring for adverse reactions.
She pointed out that the number of prescribers will tend to be
specialists involved with chronic diseases such as arthritis and
lupus. She asserted that the specialists will be aware that
biologicals are available and more affordable for patients.
SENATOR HUGHES communicated that biological products were
currently not inexpensive and asserted that SB 32 is needed for
pharmacists to stock biologicals in order to be ready for
prescriptions, otherwise pharmacists will not make biologicals
available and Alaskans will miss out on the opportunity. She set
forth that biological products are going to be a safe and
affordable option upon FDA approval. She conceded that
biological products are a new concept that will require a bit of
education.
She noted that generics are accepted because they are chemically
identical; however, there is confusion that a biological product
like Humira will be substituted with a biosimilar. She pointed
out that a biosimilar has not been approved to be
interchangeable and that was another reason why SB 32 is needed
because currently a pharmacist could interchange a biosimilar
and that would not be a violation of state law and the patient
could have an adverse effect.
She summarized that SB 32 is important to make sure that
substituting occurs with the interchangeable biosimilars and
that the practice is in law. She set forth that SB 32 is needed
now rather than later because biosimilars are expected within
six months to a year.
1:52:41 PM
SENATOR BEGICH revealed that all of the information he has
received regarding interchangeable biological products has been
very positive. He asked if there has been any organized
opposition from Alaska or any of the states that have been
reviewed.
SENATOR HUGHES replied that she is not aware of organized
opposition. He disclosed that there have been some prescribers
that have been concerned. She reiterated that there has been a
tug-of-war between prescribers and pharmacists regarding
notification. She added that the bill applies to an FDA
interchangeable that should not cause the reactions that
patients might be concerned about.
CHAIR WILSON pointed out that most of the biological medications
are not stocked on pharmacy shelves and the majority are mail
ordered. He noted that most people he knows that get their
biologics directly through their doctor's office do so without
having to go to a pharmacy. He asked how dealing directly with
doctors impacts mail-order purchases.
SENATOR HUGHES revealed that the Alaska Pharmacists Association,
a medical doctor and a pharmacist from the College of Pharmacy
in Arizona are available to answer Chair Wilson's question.
1:55:43 PM
CHAIR WILSON opened public testimony on SB 32.
1:56:28 PM
RYLAN HANKS, Director, Global R&D and Regulatory Policy, Amgen
Incorporated, Los Angeles, California, testified in support of
SB 32. He explained that Amgen is a manufacturer of both
innovative biologic medicines and has leveraged their 35 years
of experience to start making biosimilar medications. He said
Amgen sees the value in the importance of biosimilar medication
to its patients.
He noted that generic drugs provide a bit of a conceptual
overview or framework about today's biosimilars and
interchangeable biologics, but noted that there is a difference.
He detailed that biologics are much more complex in size and
structure than traditional chemical drugs; i.e. small tablet-
based pills. He revealed that the size difference is quite
immense, on the order of 800 to 1,000 times larger than a
chemical drug. He added that biologics are largely protein-based
products that are much more complex than traditional medicines.
He pointed out that biologics and biosimilars will be things
that are highly similar, but not exactly the same as referred to
earlier. He emphasized that biologics and biosimilars are
products that have been rigorously tested by the FDA.
He disclosed that biologics, biosimilars and interchangeable
biologics are granted authority to the FDA to approve. He
explained that there are two standards to meet: biosimilar and
interchangeable biologic. He specified that biosimilar meets a
certain standard which means it can be used in practice and does
not cause any clinical effect or adverse problems to a patient,
and it should be in a "good standard."
He specified that an interchangeable biologic must meet a
biosimilar standard with no clinical differences, including
looking at switching back and forth between the original product
and the proposed interchangeable product. He added that the
interchangeable biologic must also show no significant
differences in safety or efficacy.
He set forth that when an interchangeable biologic is approved,
the product will have been vetted significantly with an
understanding that the FDA's process also addressed switching
back-and-forth and safety when the products come to market.
1:59:52 PM
MR. HANKS summarized that biosimilars and interchangeable
biologics are going to be highly important medicines for
patients by providing additional access for affordable and cost
saving medicines for Alaskan patients. He opined that SB 32 is
truly a patient-first bill that will improve patients' lives for
very serious and chronic medical conditions.
SENATOR MICCICHE asked if Amgen produces biologics and
biosimilars.
MR. HANKS answered yes.
SENATOR MICCICHE said he referenced data that says no two
biologics are exactly the same, just as no two finger prints are
exactly the same. He asked if different batches of Amgen's
biologics are also not the same.
2:01:06 PM
MR. HANKS answered that the biologics' batches can have slight
variability, but manufacturers' batch-to-batch production of a
biologic medicine have specific controls in place to manufacture
within a tight spectrum. He added that the biologics are
rigorously tested, have additional scientific criteria, and
noted their long history with manufacturing the same product. He
admitted that a slight variation can happen, but the variation
is within a very tight and narrow window, so it does not cause
an effect. He reiterated that the FDA reviews biologics' for
causing changes. He detailed that biosimilars are a significant
kind of development based on a novel product that takes the
original product and a biosimilar process is created from
scratch to make new biosimilars, so each batch is a little bit
distinct.
2:02:04 PM
SENATOR MICCICHE referenced a Rand Corporation prediction that
biosimilar savings between 2014 and 2024 will be $44.2 billion.
He cited an Express Scripts estimation that potential savings
between 2014 and 2014 will be $250 billion, a 500 percent
difference from the Rand prediction. He asked why there are
savings when the process sounds the same. He inquired if the
biosimilar process is as rigorous.
MR. HANKS explained that the FDA looks at biosimilars as a
product that already has an established and efficacious
reference product. He specified that biosimilars have to meet a
standard of comparable safety and efficacy where new safe and
efficacious standards do not have to be established. He
summarized that cost savings are realized from the biosimilars'
development process.
SENATOR VON IMHOF asked what the benefits are from switching
back and forth, other than cost.
MR. HANKS replied that switching back and forth will provide
some flexibility for physicians when medication options are
considered. He reiterated that biosimilars' profiles will not be
exactly the same and prescribers will be able to establish the
best product from multiple options.
2:04:23 PM
SENATOR VON IMHOF remarked that genetic research will allow
medications to be fine-tuned for the person. She asked what can
happen in three days between the time that the pharmacist
dispenses an interchangeable biologic and the time that the
doctor is notified.
MR. HANKS admitted that he is not an expert on immunogenicity;
however, he disclosed that Amgen does not predict an immune
response from a patient in a short period of time. He said Amgen
does not expect to see concerns, issues or adverse events that
happen quickly after a patient moves from one biologic product
to interchangeable biologic products. He explained that Amgen's
expectations are based on the extensive research done on moving
back and forth between products. He pointed out that
communication and updating patients' medical records are key.
SENATOR BEGICH asked if any projections were done for the
potential savings in Alaska that might occur from the change.
MR. HANKS replied not to his knowledge.
2:06:32 PM
SENATOR GIESSEL asked when Mr. Hanks anticipates the FDA will
approve the interchangeable biologics.
MR. HANKS answered that he could not provide a specific time,
but noted that he expects interchangeables in the near future.
SENATOR GIESSEL asked why rush SB 32 if FDA approval is not
known. She inquired why speeding up the FDA approval process
would be considered when the diseases and medications are
complex.
2:08:06 PM
MR. HANKS explained that the rationale behind introducing
legislation at the current time is to clarify interchangeable
biologic use and to make clear what a similar should not be used
as. He opined that the urgency is based on the fact that
biosimilars are coming to the market and being used by patients.
He said there needs to be clearly defined rules on appropriate
use of interchangeable biologic products.
He asked that Senator Giessel clarify her questions pertaining
to speeding up the approval process.
SENATOR GIESSEL replied that when the FDA will provide approval
is not known. She asked why not wait for FDA approval. She
pointed out that approval could take two years.
MR. HANKS reiterated that interchangeables are coming with the
need to clarify and provide rules around how to use biosimilars.
He pointed out that Alaska has nothing in state law in the
Pharmacy Practice Act about either biosimilar or an
interchangeable. He noted that Senator Hughes discussed the
possible impact if a pharmacist does not have clear ideas about
how to use either of the two products. He added that multiple
biosimilars are currently under FDA review and a robust increase
could occur during the current year.
SENATOR GIESSEL asked Chair Wilson if the Board of Pharmacy will
be available to address questions from the committee.
CHAIR WILSON replied that he did not see a representative from
the Board of Pharmacy. He suggested that questions could be
asked for follow up if the board could present.
2:10:53 PM
DR. DAVID CHARLES, Chair, Alliance for Patient Access,
Nashville, Tennessee, testified in support of SB 32. He detailed
that AFPA is a national organization consisting of several
hundred physician members across various specialties including
urology, rheumatology, dermatology, oncology, and so forth. He
noted that many of the member specialists use biologics. He
added that he is a neurologist and uses biologics in his
practice.
DR. CHARLES stated that biologics are revolutionizing the care
of people with a host of conditions including cancer, arthritis,
inflammatory bowel disease, and multiple sclerosis. He said
biologics are phenomenal and provide treatments that were not
available before.
He declared that he endorsed SB 32 and remarked that the
provisions in the bill are excellent. He agreed that there is
some back-and-forth between physicians and pharmacists about the
medication and how substitutions will be handled.
He explained that the FDA is addressing two types of
biosimilars: regular biosimilars and interchangeable
biosimilars. He specified that for the pharmacist to be able to
substitute there are really only those that are interchangeable.
He opined that many physicians may be comfortable with the
pharmacy doing the change with interchangeable biosimilars. He
remarked that SB 32 got it right because the bill keeps the
ability of the physician to write, "Dispense as written."
He stated that SB 32 struck the right balance in notification.
He added that communication is key between the pharmacists and
prescribers. He opined that AFPA members would agree with a
timely notification within 72 hours to update patient records
and noted that SB 32 says 3 days. He noted that bills across the
U.S. are striking the balance of compromise between physicians
and pharmacists. He added that he agreed with including the,
"Dispense as written" part if there was a concern by a physician
when medically necessary.
2:16:43 PM
DR. PHILIP SCHNEIDER, Chair, Advisory Board, Alliance for Safe
Biologic Medicines (ASBM), Phoenix, Arizona, testified in
support of SB 32. He detailed that that ASBM is a group of
patients, physicians, pharmacists and manufacturers working
towards the safe introduction and use of biosimilars. He
asserted that biologic medicines have helped patients with some
of the serious chronic conditions like cancer, immune disorder,
arthritis, diabetes, Crohn's disease, and multiple sclerosis
(MS); copies of these medicines called biosimilars are becoming
available in the U.S. and they have the potential for new
therapeutic options for patients at lower costs.
He specified that unlike generic versions of simple chemical
drugs, biosimilars are not exact duplicates of the reference
product. He pointed out that due to the complexity of the
biologics in the proprietary manufacturing process, they are
viewed as copies and can only be similar and never the same. He
disclosed that the smallest structural difference between the
biologic and its biosimilar can have a significant impact on
patients. He disclosed that regulators, including the FDA and
the World Health Organization, have made "naming" to distinguish
products a priority in order to make inadvertent substitution
less likely. He set forth that with biosimilars it is critical
that the physician, pharmacist, patient and regulators know what
medicine the patient is actually receiving.
DR. SCHNEIDER explained that current Alaska law does not provide
a clear pathway to the substitution of biosimilar drug products;
therefore, pharmacist will need to require advanced approval
from the prescriber before substituting an interchangeable
biologic for a brand-name biologic, a provision that SB 32 will
remove. He detailed that SB 32 will allow Alaska pharmacists
with the ability to dispense safe and less expensive biologic
medicines to patients by allowing the substitution of
interchangeable biologic that are prescribed for anything
biologic. He asserted that SB 32 protects patients and ensures
only FDA approved interchangeable biologic products may be
substituted without prior prescriber consent, this is similar to
substitution requirements of generic substitution. He added that
physicians will retain the authority to write, "Dispense as
written" which is identical to the authority for generic
substitution.
He pointed out that because biologic products differ from
generics in their complexity and are not identical, the
legislation assures that there will be a clear and timely
communication between pharmacists and prescribers to ensure
patient records reflect which specific product is being
dispensed to the patient. He said pharmacists will have up to
three-business days to relay medication information that is
being dispensed so all providers have an accurate patient
medical record. He stated that having an accurate patient
medical record allows providers to assess the patient's response
to a particular treatment.
He set forth that ASBM and various pharmaceutical, pharmacy and
insurance companies support SB 32 because the legislation
provides a clear substitution process by which pharmacists can
dispense a FDA approved interchangeable biologic without first
seeking approval. He added that the bill also increases access
to lower-cost medicines for patients. He added that SB 32 is
similar to legislation that has been passed in 26 states and
Puerto Rico.
DR. SCHNEIDER summarized that ASBM supports SB 32 because the
bill removes barriers to low-cost medicines and increases
treatment options while recognizing the need for transparency
and communication among health-care providers to ensure patient
safety when using the promising new biologic medicines.
2:22:25 PM
MARK GUIMOND, Director of State Legislative Affairs, Arthritis
Foundation, Washington, D.C., testified in support of SB 32. He
set forth that biologics for the arthritis community are
critical. He said biologics have changed in a generation, the
difference for children in particular with juvenile arthritis
that were living their lives in a wheelchair to going out and
playing. He stated that the Arthritis Foundation wants to make
sure biologics are available to everybody.
He pointed out that biosimilars as a science offers the
opportunity to have new biologics come to market that are proven
and safe. He revealed that the new drugs coming to market are
innovative, less expensive and more available to people. He said
the Arthritis Foundation wants to change lives in the arthritis
community and biologics does that.
He set forth that the Arthritis Foundation supports a post-
substitution notification as specified in the bill from the
pharmacist to the prescriber because the mechanism in the
legislation will be consistent with federal law.
2:25:53 PM
GARY MCCLELLAND, Patient Advocate, Anchorage, Alaska, testified
in support of SB 32. He revealed that he is a cancer patient. He
set forth that the additional options provided by biological
medicine allows him to receive treatment in Anchorage rather
than having to travel to the Lower 48. He added that making
biosimilars available in a short period of time will be a cost-
cutting measure for himself, other patients and the state.
2:28:19 PM
ROBERT THOMS, representing himself, Wasilla, Alaska, testified
in support of SB 32. He revealed that he has rheumatoid
arthritis and uses Humira. He revealed that using Humira has
allowed him to enjoy a functional life.
2:32:27 PM
CINDY CASERTA, representing herself, Wasilla, Alaska, testified
in support of SB 32. She disclosed that she is the wife of Mr.
Thoms and confirmed that Humira has helped him. She asserted
that Mr. Thoms and other Alaska residents can benefit from
additional options if the FDA approves more biosimilars. She
said the passage of SB 32 will allow patients to make informed
choices about other, perhaps cheaper biologics. She added that
patients' doctors and others will be notified within days and
together they can modify the biologic's effect.
2:35:19 PM
ASHLYN ANTONELLI, representing herself, Anchorage, Alaska,
testified in support of SB 32. She asserted that biological
drugs are necessary and noted that she would not be at the
committee meeting without the use 0f biologics. She added that
she supported SB 32 due to the potential cost savings from
biological drugs as well.
2:42:02 PM
EMILY NENON, Alaska Government Relations Director, American
Cancer Society Cancer Action Network, Anchorage, Alaska,
testified in support of SB 32. She set forth that SB 32 is an
opportunity to update state statutes to keep up with the
advances in medical science. She asserted that biologic drugs
are providing tremendous promise in the treatment of cancer. She
revealed that there are currently no FDA-approved
interchangeable biosimilars for cancer treatment; however, there
are a number in the research pipeline and statutes will need to
be updated.
She revealed that biologic drugs are some of the most expensive
cancer drugs on the market today. She noted that just as
generics have done for small molecule drugs, interchangeable
biosimilars have the potential to increase price competition
with some of the older biologic drugs and result in lower cost
burdens for cancer patients.
She summarized that there are three-basic principles that are
important to the American Cancer Society Cancer Action Network
regarding legislation: consent, notification and record keeping,
and safety and interchangeability.
2:45:18 PM
DR. BARRY CHRISTENSEN, Co-Chair, Alaska Pharmacist Association,
Ketchikan, Alaska, testified that the Alaska Pharmacist
Association is neutral on SB 32. He addressed previous testimony
and noted that most pharmacies in Alaska are currently
dispensing biological products, mostly in the form of insulin
and drugs for rheumatoid arthritis.
DR. CHRISTENSEN announced that the Alaska Pharmacist Association
is neutral on SB 32, mostly because the association has not had
enough time to review the legislation. He noted that the
association has asked for clarification on part of the naming
portion of the bill on page 2. He detailed that naming will
impact pharmacy software systems for correct labeling.
SENATOR GIESSEL asked if pharmacists in Alaska currently
dispense biosimilars.
DR. CHRISTENSEN replied that biosimilars are new territory, but
will definitely be part of the future. He said he believed that
some biosimilars are being dispensed. He noted that one of the
bigger biosimilars that have come on the market is one of the
long-acting insulins that insurance companies are promoting for
its lower costs.
2:48:04 PM
SENATOR GIESSEL asked if an Alaskan pharmacist at this time
would make a substitution for either a biosimilar or a biologic
without consulting the prescriber and getting affirmation from
the prescriber.
DR. CHRISTENSEN answered no. He specified that currently all
pharmacists should be getting a new prescription for the
biosimilar product.
SENATOR BEGICH asked how consent communication would work with
mail-order companies. He inquired if the consent requirement
would essentially prohibit the use of mail order for
biosimilars.
DR. CHRISTENSEN replied that he did not see a problem with
compliance because information can be sent electronically via
the insurance-side of things.
2:50:02 PM
LIS HOUCHEN, Chair, National Association of Chain Drugstores
(NACDS), Anchorage, Alaska, testified that the NACDS is neutral
on SB 32 if notification is changed from three-business days to
five-business days. She set forth that a change to Section 5,
line 28 from a three day to a five-day notification would
provide a larger reporting window in the event that something
outside of a pharmacist's control occurs.
2:51:52 PM
CHAIR WILSON closed public testimony on SB 32.
2:52:18 PM
CHAIR WILSON held SB 32 in committee for future consideration.
2:52:57 PM
There being no further business to come before the committee,
Chair Wilson adjourned the Senate Health and Social Services
Committee at 2:52 p.m.